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Completed

NCT Number: NCT00961805

Effectiveness of Dance on Patients With Fibromyalgia

The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo

São Paulo, 04023-090, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • classification of fibromyalgia based on the criteria of the American College of Rheumatology
  • female gender
  • aged between 18 and 65 years

Exclusion criteria

  • not having altered treatment in previous three years
  • having signed a term of informed consent
  • patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded

Treatment and study plan

dance

Behavioral

Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Control Group

Other

The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).

Primary outcomes

  1. Visual Analog Scale for Pain

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 and 100 where 0 is no pain and 100 in unbearable pain

Secondary outcomes

  1. Function - 6 Minute Walk Test

    Time frame: baseline, after 16 weeks and after 32 weeks

    meters traveled on a 20-meter course over a six-minute period

  2. Quality of Life - Fibromyalgia Impact Questionnaire

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment

  3. Quality of Life - SF-36 -Functional Capacity

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  4. Quality of Life - SF-36 - Physical Limitation

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  5. Quality of Life - Sf-36 - Pain

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  6. Quality of Life - Sf-36 - General Health State

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  7. Quality of Life - SF-36 - Vitality

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  8. Quality of Life - SF-36 - Social Aspects

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  9. Quality of Life - SF-36 - Emotional Aspects

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  10. Quality of Life - SF-36 - Mental Health

    Time frame: baseline, after 16 weeks and after 32 weeks

    score between 0 from 100, with higher scores denoting better quality of life

  11. Depression - Beck Inventory

    Time frame: Baseline, after 16 weeks and after 32 weeks

    score between 0 from 63, with higher score indicating greater depression

  12. Self-image - Body Dysmorphic Disorder Examination Questionnaire

    Time frame: Baseline, after 16 weeks and after 32 weeks

    scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Aug 19, 2009
Registry last updated
Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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